Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy
1 other identifier
interventional
153
6 countries
24
Brief Summary
The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Dec 2008
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedSeptember 16, 2013
March 1, 2011
1.2 years
December 17, 2008
September 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.
12 weeks
Secondary Outcomes (1)
To determine the safety and tolerability of BG00012 with methotrexate in this population.
12 weeks
Study Arms (3)
1
ACTIVE COMPARATORBG00012 480 mg/day
2
ACTIVE COMPARATORBG00012 720 mg/day
3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- must be taking methotrexate
- inadequate response to at least one conventional DMARD
- swollen and tender joint count
You may not qualify if:
- previous treatment with TNF or any other biologic or prosorba column
- Other criteria also apply.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (24)
Research Site
Woolloongabba, Queensland, 4102, Australia
Research Site
Woodville, South Australia, 5011, Australia
Research Site
Sarnia, Ontario, N7T4X3, Canada
Research Site
New Market, Canada
Research Site
Ottawa, Canada
Research Site
Rothesay, Canada
Research Site
Active, Not Recruiting, Czechia
Research Site
Pardubice, Czechia
Research Site
Uh. Hradiste, Czechia
Research Site
Zlín, Czechia
Research Site
Bangalore, India
Research Site
Hyderabaad, India
Research Site
Hyderabad, India
Research Site
Lucknow, India
Research Site
Bialystock, Poland
Research Site
Grodzisk Mazowiecki, Poland
Research Site
Lublin, Poland
Research Site
Poznan, Poland
Research Site
Torun, Poland
Research Site
Warsaw, Poland
Research Site
Banska Bysterica, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Košice, Slovakia
Research Site
Piešťany, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 18, 2008
Study Start
December 1, 2008
Primary Completion
February 1, 2010
Study Completion
March 1, 2010
Last Updated
September 16, 2013
Record last verified: 2011-03